EMMA: Empowerment, Motivation and Medical Adherence

Not Applicable

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Behavioral: EMMA

• Registration Number: NCT02295696
• Lead Sponsor: Steno Diabetes Center Copenhagen

Brief Summary

EMMA: Empowerment, Motivation and Medical Adherence. A consultation program based on dialogue tools for adults with poorly regulated Type 2 diabetes.

Detailed Description

Traditionally, the success of patients to manage their diabetes has been judged by their ability to adhere to a prescribed therapeutic regimen, and efforts have been spent developing strategies to promote adherence. It is estimated that 20% to 50% of patients with chronic conditions are not adherent to their prescribed medication regimen, with non-adherence being defined as \<80% adherence to prescribed, relevant medication. The treatment regimen often comprises several elements such as poly-pharmacy including insulin administration, self-monitoring of blood glucose, diet and physical exercise. It is thus not just a matter of 'taking a pill or not' but implies lifestyle changes, knowledge and competence, and internal motivation for self-management. The investigators developed a consultation program based on dialogue tools. The EMMA program aims to support medication adherence and blood glucose control by facilitating rapport, exploring patient concerns and challenges, enabling knowledge exchange and supporting goal-setting and action-planning. A pilot test of the program appeared feasible and acceptable to patients and health care professionals and showed significant decrease on HbA1c. EMMA is now ready to be tested in a randomized controlled study (RCT) study.

Study Timeline

• Status Verified: 2014-11
• Study Start: 2014-11
• Study First Submitted: 2014-11-05
• Study First Submitted QC: 2014-11-19
• Study First Posted: 2014-11-20
• Last Update Submitted: 2014-11-20
• Last Update Posted: 2014-11-21
• Primary Completion: 2017-08
• Study Completion: 2017-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

• Adults Type 2 diabetes ≥ 18 år
• Type 2 diabetes ≥ 1 år
• HbA1c ≥ 64 mmol/mol (≥ 8%) at the last three measures before randomisation
• Taking medication for Type 2 diabetes • - Speak, read and understands Danish

Exclusion Criteria

• Participating in other intervention research projects during the trial period
• Being treated by a psychiatrist or psychologist during the period
• Reduced sight or blindness

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention group	EMMA	Intervention arm : EMMA consultations

Primary Outcome Measures

Name	Time	Method
HbA1c	Baseline, 4½ month and 6 months after end of intervention period	Change from baseline in HbA1c at 4½ month which is maintained or improved at 6 months

Secondary Outcome Measures

Name	Time	Method
Self-management	Baseline, 4½ month and 6 months after end of intervention period	Change from baseline in Self-management skills at 4½ month assessed by increase in the Treament Self-Regulation Questionnaire (TSRQ scale) which is maintained or improved at 6 months

Trial Locations

Locations (1)

Gitte R Husted; 🇩🇰 Gentofte, Denmark